Testosterone (Transdermal)

Testosterone (Transdermal) patch is used to treat men whose bodies do not produce enough natural testosterone, which is known as hypogonadism. Testosterone is a male hormone that plays a key role in the growth and development of male sex organs and in maintaining secondary sex characteristics.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits. This allows your doctor to see if the medicine is working properly and to check for any problems or unwanted effects that may be caused by this medicine. Blood tests will be needed to check for unwanted effects.

This medicine should not be used by women who are pregnant or might become pregnant. Testosterone may cause birth defects if a pregnant woman comes in contact with the patch or medicine. Make sure your doctor knows if your sexual partner is pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away.

If a woman comes in contact with the patch, wash the skin area right away with soap and water to remove all the medicine. If the patch sticks to a woman, remove the patch right away and wash her skin thoroughly with soap and water.

If your female partner starts to have male-like changes such as unusual hair growth or increased acne, check with your doctor.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

This medicine may increase the risk of prostate cancer, especially in older men. Make sure your doctor knows if you have prostate cancer, or if anyone in your family has prostate cancer.

This medicine may cause blood clotting problems. Tell your doctor right away if you have pain, redness, or swelling in the arm or leg, shortness of breath, sharp pains in the chest, or trouble breathing.

This medicine may increase your risk of having heart or blood vessel problems, including a heart attack or stroke. Tell your doctor right away if you have chest pain that may spread to your arms, jaw, back, or neck, faintness, headache, nausea, vomiting, trouble breathing, trouble seeing or speaking, or unusual sweating.

In some cases, this medicine may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Tell your doctor if you experience too frequent erection of the penis, nausea, vomiting, yellowing of your skin or the whites of your eyes, or swelling of the ankle.

This medicine may cause swelling of the breasts (gynecomastia) and breast pain in some patients. If you have questions about this, talk to your doctor.

This medicine may cause changes in the level of cholesterol and fats in your blood. If this condition occurs, your doctor may give you a medicine to adjust the cholesterol and fats. Talk to your doctor if you have concerns.

This medicine contains aluminum that may cause skin burns at the patch site if you have a procedure called a magnetic resonance imaging (MRI) scan while you are wearing the patch. You must remove the patch before your MRI to prevent skin burns.

Check with your doctor immediately if mild, burn-like skin blisters, redness, itching, or swelling occurs at the site of application during or after treatment.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it may provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how the testosterone transdermal patch affects children. Safety and effectiveness have not been determined.

Geriatric

There have not been appropriate studies on how the testosterone transdermal patch affects older adults. However, elderly patients may have a higher risk of developing prostate issues, including prostate cancer, which may require caution when using the testosterone transdermal patch.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. You should either be given a different medication or stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there could be an interaction. If you are taking this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are particularly important but may not be the only ones.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both medicines.

• Anisindione
• Bupropion
• Dicumarol
• Levoketoconazole
• Methotrexate
• Paclitaxel
• Paclitaxel Protein-Bound
• Phenprocoumon
• Warfarin

Using this medicine with any of the following medicines may raise the risk of certain side effects, but using both may be the best option for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both medicines.

• Licorice

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food because interactions may happen. Drinking alcohol or using tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you use this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Blood clotting problems (e.g., deep vein thrombosis, pulmonary embolism) or
• Diabetes or
• History of drug abuse or dependence or
• Enlarged prostate or
• History of heart attack or
• Hypercalcemia (high calcium in the blood) or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Problems with urination or
• Sleep apnea (breathing problem) or
• History of stroke—Use with caution. May worsen these conditions.

• Blood disorder (e.g., polycythemia)—May increase the risk for thromboembolic diseases.

• Male breast cancer or
• Known or suspected prostate cancer—Should not be used in patients with these conditions.

• Heart disease (e.g., congestive heart failure) or
• Kidney disease or
• Liver disease—Use with caution. Testosterone may cause edema (fluid retention) in patients with these conditions.

• Lung disease or
• Obesity—May increase the risk for sleep apnea.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Skin itching, blistering, or redness at the application site

Less common

• Blistering, burning, crusting, dryness, or flaking of the skin
• bloody or black, tarry stools
• burning feeling at the application site
• constipation
• difficult urination
• hardening or thickening of the skin under patch
• itching, scaling, severe redness, soreness, or swelling of the skin
• pelvic pain
• severe stomach pain
• vomiting of blood or material that looks like coffee grounds

Rare

• Bladder pain
• bloody or cloudy urine
• blurred vision
• difficult, burning, or painful urination
• dizziness
• frequent urge to urinate
• headache
• lower back or side pain
• nervousness
• pounding in the ears
• slow or fast heartbeat
• testicular problems

Incidence not known

• Pain, redness, or swelling in the arm or leg

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Discouragement
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• rash
• tiredness
• trouble concentrating
• trouble sleeping

Rare

• Accelerated growth
• blemishes on the skin
• body pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• cold hands and feet
• contamination of the application site
• decreased interest in sexual intercourse
• fear
• feeling of constant movement of self or surroundings
• inability to have or keep an erection
• increased appetite
• lightheadedness
• loss in sexual ability, desire, drive, or performance
• loss of bladder control
• mood or mental changes
• pimples
• sensation of spinning
• thinking abnormalities
• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Androderm

In Canada

• Androplex

Available Dosage Forms:

• Patch, Extended Release

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Androgen

Your doctor will test the testosterone levels in your blood before you start and while you are using this medicine.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Testosterone skin patch comes in two different doses and different patch sizes. Ask your doctor which is the right one for you.

Make sure that you wash your hands with soap and water before and after applying the patch.

For patients using the patch:

• After opening the pouch that contains the patch, apply the patch immediately.
• Apply the patch to a clean, dry area of the skin on your back, abdomen or stomach, thighs, or upper arm. Do not put the patch over burns, cuts, or irritated skin. Avoid putting the patch on oily or sweaty skin, or on areas covered with hair, since the patch may not stick tightly to these areas.
• Do not apply the patch to your scrotum or genital area. Avoid applying this medicine to a bony area (such as your shoulder) or to an area that might be under pressure for a long time (such as the back of your leg when you are sitting).
• The patch can be worn during sexual intercourse, or while taking a shower or bath. Wait for at least 3 hours after applying the medicine before you shower, swim, or wash the application site. However, heavy exercise and sweating may cause the patch to fall off.
• When replacing an old patch, make sure that you apply the new patch on a different spot. Do not put another patch back on the same spot for at least 7 days.
• Do not apply any type of ointment product on your skin before you put on the patch.
• If a patch comes off, just put it back on the same spot. If the patch will not stick and you have been wearing it for fewer than 12 hours, put on a new patch. Then stay on your regular schedule and replace it with a fresh patch at your next regular time. If you have already been wearing the patch for more than 12 hours, do not put on a new patch. Wait to put on a new patch at your next regular time. Do not use extra patches to make up for the one that came off.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For transdermal dosage form (patch):For hormone replacement: Adults—At first, one 4-milligram (mg) patch applied nightly for 24 hours. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor.

Missed Dose

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Storage

Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep the medicine in a safe place. Do not give it to anyone else, even if you have the same symptoms.

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